Model Number 72912 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 01/01/2015 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; other pain: lower stomach pain and legs; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; damage.Nonsurgical treatments: on (b)(6) 2015 the patient commenced other medication (please specify): ural for the treatment of: uti's.Treatment duration: as needed.On (b)(6) 2019 the patient commenced pain medication: panadol/ibuprofen for the treatment of: pain relief, as needed.Treatment duration: 2 years.On (b)(6) 2020 the patient commenced pain medication: panadeine forte for the treatment of: pain relief, as needed.Treatment duration: 1 year.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): voltarin for the treatment of: pain relief.Treatment duration: 6 months.
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Manufacturer Narrative
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Patient identifier: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Manufacturer Narrative
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Block a1: (b)(6).Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.Block h10: the complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2020-06762.
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Event Description
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It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; other pain: lower stomach pain and legs; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; damage.Nonsurgical treatments: on (b)(6) 2015 the patient commenced other medication (please specify): ural for the treatment of: uti's.Treatment duration: as needed.On (b)(6) 2019 the patient commenced pain medication: panadol/ibuprofen for the treatment of: pain relief, as needed.Treatment duration: 2 years.On (b)(6) 2020 the patient commenced pain medication: panadeine forte for the treatment of: pain relief, as needed.Treatment duration: 1 year.On (b)(6) the patient commenced topical treatment (including oestrogen cream): voltarin for the treatment of: pain relief.Treatment duration: 6 months.
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Search Alerts/Recalls
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